Table 2

Ocular adverse events

Study eye, n (%)CLS-TA 4.0 mg
(N=38)
Total number of ocular adverse events41
Number of patients with ≥1 ocular AE19 (50.0)
Treatment-related ocular AEs7 (18.4)
Serious ocular AEs0
Treatment-related serious AEs0
TEAEs leading to study drug discontinuation0
Adverse events
 Cataract*4 (10.5)
 Cystoid macular oedema0
 Endophthalmitis0
 Eye pain†: time of procedure3 (7.9)
 Eye pain†: any time post procedure1 (2.6)
 Elevated IOP‡: time of procedure1 (2.6)
 Elevated IOP‡: pertaining to corticosteroid§5 (13.2)
 Retinal detachment0
 Suprachoroidal haemorrhage0
 Worsening of uveitis1 (2.6)
 Vitreous detachment1 (2.6)
  • *Cataract includes the medDRA preferred terms (a) cataract, (b) cataract subcapsular and (c) cataract nuclear.

  • †‘Eye pain’ includes the preferred terms (a) eye pain and (b) injection site pain.

  • ‡‘Elevated IOP’ includes the preferred terms (a) IOP increased and (b) ocular hypertension.

  • §Includes all events of elevated IOP that did not occur on the day of the procedure.

  • AE, adverse event ; CLS-TA, investigational triamcinolone acetonide injectable suspension; IOP, intraocular pressure.